The streamlined process is expected to shorten the turn-around for the CAR-T therapy to about the same time as from an office visit to front-line cancer treatment, Kite Pharma said.
Kite Pharma, Inc. believes there is more room to lower its Yescarta turn-around time even after the US Food and Drug Administration approved a two-day reduction for its CAR-T cancer treatment Yescarta.
The manufacturing supplement that the FDA cleared will allow Kite’s median turn-around time for Yescarta (axicabtagene ciloleucel) to drop from...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
